Salivary pepsin in infant gastro-oesophageal reflux disease

• Research type

  Research Study

• Full title

  Salivary pepsin for diagnosis of gastro-oesophageal reflux disease in infants

• IRAS ID

  155511

• Contact name

  Daniel Sifrim

• Sponsor organisation

  Queen Mary University of London

• Duration of Study in the UK

  2 years, 5 months, 31 days

• Research summary

  Rationale: Gastro-oesophageal reflux is the involuntary movement of gastric contents into the oesophagus and is referred to as gastro-oesophageal reflux disease (GORD) when causing troublesome symptoms and/or complications. GORD is common in infants. To prevent over/under diagnosis and treatment of infant GORD, there is a clear need to distinguish disease that resolves itself by 18 months (the majority) from more severe disease with long-term consequences.
  Currently, the proposed diagnostic tool to assess GORD is invasive monitoring with a tube passed through the nose into the oesophagus (pH-impedance), but we are not certain what the normal values for this test are (due to ethical considerations of invasive testing in healthy infants).
  Pepsin, a substance found in the stomach may be found in the saliva in the presence of gastro-oesophageal reflux. Salivary pepsin measurement has been shown a specific marker for GORD in adults. In infants the diagnostic and predictive ability of this test is as yet unknown, but samples can non-invasively be taken from healthy volunteers and patients without distress or discomfort.
  Our objective is to test the hypothesis that salivary pepsin is able to predict outcome of treatment in GERD suspected infants.

  We aim to collect samples from healthy infants to establish normal values for the test.
  Infants with symptoms suggestive of GORD will also have saliva testing, and will undergo standard care (including feed thickeners, and, if they do not respond to this, pH-impedance testing and proton pump inhibitor drug therapy). The diagnostic potential of salivary pepsin, and its ability to predict response to treatment will be assessed. If successful, salivary pepsin may offer a diagnostic role in infant GORD, and help decide on treatment strategies.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  16/LO/1037

• Date of REC Opinion

  17 Jun 2016

• REC opinion

  Favourable Opinion